Parkinson's Disease Clinical Trial
— PD/GuitarOfficial title:
Impact of Non-traditional Guitar Group Instruction on Functional Movement and Well-being in Parkinson's Disease Patients
NCT number | NCT02925065 |
Other study ID # | IRB00091797 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 5, 2018 |
Est. completion date | July 26, 2018 |
Verified date | September 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This controlled prospective cohort study is designed to assess the feasibility and effect of twice-weekly 60 minute non-traditional guitar classes on PD patient's self-reported and measurable outcomes including upper extremity function, motor findings, quality of life, mood, and cognitive findings. 24-30 individuals with PD will be randomly assigned to an early-start and a late-start guitar instruction group. Prior to conducting a larger study, this study seeks to assess the possibility that participation in an instrumental performance activity in a group setting may improve outcomes in PD patients.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 26, 2018 |
Est. primary completion date | June 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Adult patients (age 18-89) with idiopathic PD diagnosis according to the United Kingdom (UK) Brain Bank Criteria with bilateral motor symptoms. - Hoehn and Yahr Stages 1-3. - MoCA score >24 to screen out patients with dementia. Exclusion Criteria: - Prior exposure to guitar training. - History of prior trauma of the brain or upper extremities. - Inability to personally consent to study. - Inability or unwillingness to participate in twice weekly classes for 6 weeks. - Agitation or hallucinations. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University (Peabody Institute & Department of Neurology) | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Altenmüller E, Marco-Pallares J, Münte TF, Schneider S. Neural reorganization underlies improvement in stroke-induced motor dysfunction by music-supported therapy. Ann N Y Acad Sci. 2009 Jul;1169:395-405. doi: 10.1111/j.1749-6632.2009.04580.x. — View Citation
Austin D, Jimison H, Hayes T, Mattek N, Kaye J, Pavel M. Measuring motor speed through typing: a surrogate for the finger tapping test. Behav Res Methods. 2011 Dec;43(4):903-9. doi: 10.3758/s13428-011-0100-1. — View Citation
Benoit CE, Dalla Bella S, Farrugia N, Obrig H, Mainka S, Kotz SA. Musically cued gait-training improves both perceptual and motor timing in Parkinson's disease. Front Hum Neurosci. 2014 Jul 7;8:494. doi: 10.3389/fnhum.2014.00494. eCollection 2014. — View Citation
Bloem BR, de Vries NM, Ebersbach G. Nonpharmacological treatments for patients with Parkinson's disease. Mov Disord. 2015 Sep 15;30(11):1504-20. doi: 10.1002/mds.26363. Epub 2015 Aug 14. Review. — View Citation
de Dreu MJ, van der Wilk AS, Poppe E, Kwakkel G, van Wegen EE. Rehabilitation, exercise therapy and music in patients with Parkinson's disease: a meta-analysis of the effects of music-based movement therapy on walking ability, balance and quality of life. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S114-9. doi: 10.1016/S1353-8020(11)70036-0. — View Citation
Dorsey ER, George BP, Leff B, Willis AW. The coming crisis: obtaining care for the growing burden of neurodegenerative conditions. Neurology. 2013 May 21;80(21):1989-96. doi: 10.1212/WNL.0b013e318293e2ce. Epub 2013 Apr 24. Review. — View Citation
François C, Grau-Sánchez J, Duarte E, Rodriguez-Fornells A. Musical training as an alternative and effective method for neuro-education and neuro-rehabilitation. Front Psychol. 2015 Apr 28;6:475. doi: 10.3389/fpsyg.2015.00475. eCollection 2015. Review. — View Citation
Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340. — View Citation
Grau-Sánchez J, Amengual JL, Rojo N, Veciana de Las Heras M, Montero J, Rubio F, Altenmüller E, Münte TF, Rodríguez-Fornells A. Plasticity in the sensorimotor cortex induced by Music-supported therapy in stroke patients: a TMS study. Front Hum Neurosci. 2013 Sep 3;7:494. doi: 10.3389/fnhum.2013.00494. eCollection 2013. — View Citation
Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH. BMC Musculoskelet Disord. 2006 May 18;7:44. — View Citation
Hartigan, B. J., & Sarrafian, S. K. (2004). Kinesiology and functional characteristics of upper limb. In D. G. Smith, J. W. Michael, & J. H. Bowker (Eds.), Atlas of amputations and limb deficiencies: surgical, prosthetic, and rehabilitation principles (3rd Edition ed., pp. 101-116). Rosemont, IL: American Academy of Orthopaedic Surgeons.
Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. — View Citation
Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. — View Citation
Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. — View Citation
Pohl P, Dizdar N, Hallert E. The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease. Disabil Rehabil. 2013;35(26):2197-204. doi: 10.3109/09638288.2013.774060. Epub 2013 Mar 12. — View Citation
Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28. Review. — View Citation
Proud EL, Miller KJ, Bilney B, Balachandran S, McGinley JL, Morris ME. Evaluation of measures of upper limb functioning and disability in people with Parkinson disease: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):540-551.e1. doi: 10.1016/j.apmr.2014.09.016. Epub 2014 Oct 7. Review. — View Citation
Raglio A. Music Therapy Interventions in Parkinson's Disease: The State-of-the-Art. Front Neurol. 2015 Aug 31;6:185. doi: 10.3389/fneur.2015.00185. eCollection 2015. Review. — View Citation
Richard K Miller and Associates. (2012). The 2012-2013 Leisure Market Research Handbook. Loganville, GA: Richard K. Miller and Associates.
Rochester L, Baker K, Hetherington V, Jones D, Willems AM, Kwakkel G, Van Wegen E, Lim I, Nieuwboer A. Evidence for motor learning in Parkinson's disease: acquisition, automaticity and retention of cued gait performance after training with external rhythmical cues. Brain Res. 2010 Mar 10;1319:103-11. doi: 10.1016/j.brainres.2010.01.001. Epub 2010 Jan 11. — View Citation
Schneider S, Schönle PW, Altenmüller E, Münte TF. Using musical instruments to improve motor skill recovery following a stroke. J Neurol. 2007 Oct;254(10):1339-46. Epub 2007 Jan 27. — View Citation
Sheikh J.I., & Yesavage J.A. (1986): Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. In: Brink TL, editor. Clinical Gerontology: A Guide to Assessment and Intervention. Binghampton,NY: The Haworth Press. 165-173.
Van Vugt FT, Ritter J, Rollnik JD, Altenmüller E. Music-supported motor training after stroke reveals no superiority of synchronization in group therapy. Front Hum Neurosci. 2014 May 20;8:315. doi: 10.3389/fnhum.2014.00315. eCollection 2014. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility | Percentage of study completion will be used to assess feasibility of the intervention along with descriptive statistics. The study will be deemed feasible if 80% of participants complete 10 or more guitar group interventions. The factors that affect probability of attending guitar classes will also be investigated. | 6 weeks | |
Secondary | Efficacy: Quality of Life | The Parkinson disease quality of life assessment (PDQ-39) (Peto, Jenkinson & Fitzpatrick, 1998) is a questionnaire that is designed to assess PD specific health related quality of life within the last month in individuals with PD. Dimensions covered include mobility, activities of daily living, emotional well-being, stigma and social support, cognition, communication and bodily support. | 6 weeks and 12 week follow up | |
Secondary | Upper extremity motor function | Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 6 weeks and 12 weeks follow up | |
Secondary | Fine manual dexterity | Purdue pegboard test (PPBT) involves timed assembly of small items and assesses fine manual dexterity. | 6 weeks and 12 weeks follow up | |
Secondary | Gross manual dexterity | Box and block test (BBT) involves timed transfer of 2.5cm3 blocks from one container to another and assesses the gross manual dexterity. | 6 weeks and 12 weeks follow up | |
Secondary | Upper extremity activities of daily living function | Quick-Disability of Arm, Shoulder and Hand (Q-DASH) (Gummeson, Ward & Atroshi, 2006) is an 11-item questionnaire that measures the self-reported disability of upper extremity. | 6 weeks and 12 weeks follow up | |
Secondary | Upper extremity finger typing accuracy and speed | Finger typing task: Using index and middle finger to press 2 adjacent standard keyboard keys ('n' and 'm' for the right hand; 'c' and 'v' for the left hand) in alternating fashion as rapidly and accurately as possible in 60 seconds (each hand tested separately). | 6 weeks and 12 weeks follow up | |
Secondary | Cognition | Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) is a rapid cognitive screening test that assesses cognitive performance in multiple domains including visuo-spatial and executive functions, naming, memory, attention, language, abstraction, and orientation. | 6 weeks and 12 week follow up | |
Secondary | Mood | Geriatric Depression Scale (GD S-15) (Sheikh & Yesavage, 1986) is a 15 item questionnaire that assesses depression and suicide ideation in elderly individuals. | 6 weeks and 12 week follow up | |
Secondary | Social Participation | World Health Organization Disability Assessment Schedule (WHODAS 2.0) Social participation subscale. WHODAS 2.0 is a 36 item disability assessment questionnaire developed by the WHO Classification, Terminology and Standards team to measure health and disability. The social participation subscale (Domain 6) contains 8 items and measures impact of health on social participation. | 6 weeks and 12 weeks follow up | |
Secondary | Group participation | Pittsburg Rehabilitation Participation Scale (PRPS) will be used to monitor participation intensity and quality of the participants in the guitar group intervention. | 6 weeks and 12 weeks follow up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
Terminated |
NCT02894567 -
Evaluation of Directional Recording and Stimulation Using spiderSTN
|
N/A | |
Completed |
NCT02939391 -
A Study of KW-6356 in Subjects With Early Parkinson's Disease
|
Phase 2 |